Novartis receives FDA approval for Zortress

The US Food and Drug Administration (FDA) has approved Zortress oral tablets for the prevention of rejection of kidney transplants in adult patients at low-to-moderate immunologic risk.

Zortress is to be given in combination with reduced doses of the calcineurin inhibitor (CNI) cyclosporine, as well as basiliximab and corticosteroids. Under the brand name Certican®, everolimus is already an established part of the immunosuppressive regimen for transplant patients in more than 70 countries outside the US.